Device and method of delivering particles in the upper respiratory tract

ABSTRACT

A method of delivering a substance in aerosol or powder form to the upper respiratory tract is provided. The substance is orally administered into the larynx, through the pharynx, and out from the nose while minimizing inhalation into the lungs, whereby deposition of particles in the upper respiratory tract is achieved with limited deposition in the trachea, lower airways and lungs. Also provided is an oral delivery device having a mouthpiece for oral inhalation of a flow of a substance into the upper respiratory tract and a flow restrictor for enabling arrestment of the flow minimizing inhalation into the trachea, lower airways and lungs, which provides for a deposition of particles in the upper respiratory tract with limited deposition in the trachea, lower airways and lungs. Also provided is an oral delivery device having a mouthpiece for admission of a flow of a substance into the upper respiratory tract and a flow generator for pressuring the substance into travel through the upper respiratory tract.

This application is a continuation application of PCT applicationPCT/CA2017/050027 filed on Jan. 11, 2017, which claims priority of U.S.provisional application 62/312,878 filed on Mar. 24, 2016.

TECHNICAL FIELD

The invention relates to the medical industry, and more specifically, tothe delivery of particles in the respiratory tract.

BACKGROUND

The upper airway cough syndrome causes chronic cough and pharyngealsecretions. These syndromes are often attributable to post nasal dripand rhinitis, which is an inflammation of the mucosal lining the nasalcavity that may block the nasal airways.

One of the main treatments consists in administering aerosolizedcorticosteroid through the nasal airways. The patient sprayscorticosteroid through the nostrils and inhales in hopes that the flowof corticosteroid particles will travel through the nose, into theoropharynx, and possibly into the larynx to eliminate, or at the veryleast reduce the symptoms of the upper airway cough syndrome. However,the flow of particles is often arrested in the anterior region of thenasal cavities due to anatomical encumbrances in the form of turbinates,which may be swollen, particularly in patients suffering from rhinitis.This prevents sufficient deposition of particles in the regionsproducing the aforementioned secretions: the posterior region of thenasal cavity, the pharynx, and the larynx. As a result, the treatment isoften of limited effectiveness.

Deposition of particles in the pharynx and larynx can be achievedincidentally through oral inhalation of asthma medication. Acorticosteroid or other asthma medication may be packaged in apressurized canister operably connectable with a mouthpiece. The patientinserts the mouthpiece in the mouth, depresses the canister, whichreleases the corticosteroid in aerosolized form, and inhales thereleased corticosteroid from the mouthpiece, through the oral andlaryngeal cavities, and into the lungs. The majority of thecorticosteroid is deposited on the airways of the lungs, causing limitedreflux on the following exhalation.

SUMMARY

It is an object of the present invention to provide a method foreffective deposition of particles in the oral, laryngeal, pharyngeal,and nasal cavities with limited deposition in the trachea, lower airwaysand lungs. The purpose of the deposition can be for treatment of adisease of the upper airway or simply as a delivery tool of a medicineto the bloodstream.

The Applicant has found that in a method of delivering a dose of asubstance in the upper respiratory tract, the step of orallyadministering the substance in aerosol or powder form into the larynx,through the pharynx, and out from the nose while minimizing inhalationof the substance into the trachea, lower airways and lungs provides theadvantage of a deposition of particles of the substance in the oral,laryngeal, pharyngeal, and nasal cavities with limited deposition in thetrachea, lower airways and lungs.

In accordance with an embodiment of the present invention, there isprovided a method of delivering a dose of a substance in aerosol orpowder form to the upper respiratory tract, the method comprising thestep of orally administering the substance into the larynx, through thepharynx, and out from the nose while minimizing inhalation of thesubstance into the lungs whereby deposition of particles of thesubstance in the oral, laryngeal, pharyngeal, and nasal cavities isachieved with limited deposition of the particles in the trachea, lowerairways and lungs.

It is an object of the present invention to provide a method of treatinga disease of the upper respiratory tract.

The Applicant has found that in a method of treating a disease of theupper respiratory tract involving administration of a therapeuticallyeffective dose of a medicament in aerosol or powder form into therespiratory tract, the step of administering the dose orally into thelarynx, through the pharynx, and out from the nose while minimizinginhalation into the lungs provides the advantage of a deposition ofparticles of the medicament in the oral, laryngeal, pharyngeal, andnasal cavities with limited deposition in the trachea, lower airways andlungs.

It is an object of the present invention to provide an oral deliverydevice for effective deposition of particles in the oral, laryngeal,pharyngeal, and nasal cavities with limited deposition in the trachea,lower airways and lungs.

The Applicant has found that in an oral delivery device for delivering asubstance in aerosol or powder form to the respiratory tract, the oraldelivery device having a mouthpiece adapted to be received in the mouthfor oral inhalation of a flow of the substance into the respiratorytract, a flow restrictor for enabling arrestment of the flow beforeinhalation into the lungs provides the advantage of effective depositionof particles in the oral, laryngeal, pharyngeal, and nasal cavitiesfollowing nasal exhalation, and this, with limited deposition in thetrachea, lower airways and lungs.

In accordance with one aspect of the present invention, there isprovided an oral delivery device for delivering a dose of a substance inaerosol or powder form to the upper respiratory tract, the deliverydevice comprising a mouthpiece adapted to be received in the mouth fororal inhalation of a flow of the substance into the upper respiratorytract; and a flow restrictor for enabling arrestment of the flow beforeinhalation into the trachea, lower airways and lungs, whereby a nasalexhalation of the flow following the arrestment completes a depositionof particles of the aerosolized substance in the oral, laryngeal,pharyngeal, and nasal cavities with limited deposition of the particlesin the trachea, lower airways and lungs.

The Applicant has also found that in an oral delivery device fordelivering a dose of a substance in aerosol or powder form to therespiratory tract, the oral delivery device having a mouthpiece adaptedto be received in the mouth for oral admission of a flow of thesubstance into the respiratory tract, a flow generator for pressuringthe substance into the flow travelling through the mouthpiece, into themouth, and out from the nose while inhalation is avoided provides theadvantage of effective deposition of particles in the oral, laryngeal,pharyngeal, and nasal cavities following nasal exhalation, and this,with limited deposition in the trachea, lower airways and lungs.

In accordance with one aspect of the present invention, there isprovided an oral delivery device for delivering a dose of a substance inaerosol or powder form to the upper respiratory tract, the oral deliverydevice comprising a mouthpiece adapted to be received in the mouth foradmission of a flow of the substance into the upper respiratory tract;and a flow generator for pressuring the substance into the flowtravelling through the mouthpiece, into the mouth, and out from the nosewhile inhalation is avoided, whereby the dose is delivered with limiteddeposition of the particles in the trachea, lower airways and lungs.

According to yet another embodiment of the invention, there is provideda use of a corticosteroid in the manufacture of a medicament to beorally administered in aerosol or powder form in the oral, laryngeal,pharyngeal, and nasal cavities for the treatment of a disease of theupper respiratory tract.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be better understood by way of the following detaileddescription of embodiments of the invention with reference to theappended drawings, in which:

FIG. 1 is a partial saggital view of the respiratory tract where theflow of a substance through the upper respiratory tract is indicated byan arrow;

FIG. 2 is a side elevation, cross-section view of a first embodiment ofthe oral delivery device of the present invention having a chamber influid communication with the ambient atmosphere and with a mouthpiecethrough openings sized to restrict inhalation rates;

FIG. 3 is a side elevation, cross-section view of a second embodiment ofthe oral delivery device of the present invention having the chamber influid communication with the ambient atmosphere through an opening sizedto restrict inhalation rates, the chamber and the mouthpiece beingpositioned along a longitudinal axis of the device;

FIG. 4 is a side elevation, cross-section view a third embodiment of theoral delivery device of the present invention having a sensor foremitting a signal upon sufficient inhalation and a shutter for arrestinginhalation in response to the signal;

FIG. 5 is a side elevation cross-section view of a fourth embodiment ofthe oral delivery device of the present invention having a mouthpiece inwhich the substance is sprayed directly, the device having a sensor foremitting a signal upon sufficient inhalation and a shutter for arrestinginhalation in response to the signal;

FIG. 6 is a side elevation, cross-section view of a fifth embodiment ofan oral delivery device of the present invention, the device having aplunger moveably mounted within a chamber to pressure its content into aflow travelling through the upper respiratory tract;

FIG. 7 is a side elevation, cross-section view of a sixth embodiment ofthe oral delivery device of the present invention having a chamber inthe form of a bellows collapsible to pressure its content into a flowtravelling through the upper respiratory tract;

FIG. 8 is a side elevation, cross-section view of a seventh embodimentof the oral delivery device of the present invention, the device havinga ventilation element configured to pressure the content of a chamberinto a flow travelling through the upper respiratory tract whileinhalation is avoided; and

FIG. 9 is a side-elevation, cross-section view of an eighth embodimentof the oral delivery device of the present invention, the deviceincorporating a powder delivery inhaler.

DETAILED DESCRIPTION

The invention relates to the medical industry, and more specifically, tothe delivery of particles to the respiratory tract. It is an object ofthe present invention to provide a method for effective deposition ofparticles in the oral, laryngeal, pharyngeal, and nasal cavities withlimited deposition in the trachea, lower airways and lungs.

Referring to FIG. 1, there is shown the respiratory tract. It issometimes desirable to deliver particles of a substance in the oralcavity 302, the laryngeal cavity 304, the pharyngeal cavity 306, and thenasal cavities 308, whether for the treatment of a medical condition ofthe upper respiratory tract, such as post-nasal drip or upper airwaycough syndrome, to improve the condition of the upper respiratory tract,or for expedited delivery within the blood stream. A nasally inhaledflow of the substance is often arrested in the anterior region of thenasal cavities 308 due to anatomical encumbrances, particularly in aperson suffering from rhinitis, which prevents sufficient deposition ofparticles in the laryngeal cavity 304, the pharyngeal cavity 306, andpart of the nasal cavities 308.

The method of the present invention provides for a more effectivedeposition of particles. In application, the user orally administers thesubstance in aerosol or powder form into the pharyngeal cavity 306, thelaryngeal cavity 304, and possibly the tracheal cavity 310, and outthrough the pharyngeal cavity 306 and from the nasal cavities 308, asshown by the arrow, while minimizing inhalation into the trachea 310,lower airways 312 and lungs 314. As the administered substance travelsthrough the upper respiratory tract without any anatomical hindrancessuch as those found in the nasal cavities 308, particles are depositedalong the way onto the inner lining to achieve the desired effect. It isimportant to note that in applying the method, the user minimizes anydeposition into the lower airways 312 and lungs 314 as such depositionwould be needless, could compromise the effectiveness of the method byreducing the number of particles available for deposition in thelaryngeal cavity 304, the pharyngeal cavity 306 and the nasal cavities308, and could be harmful in cases where inhalation into the lowerairways and lungs 314 could cause damage.

In some embodiments, once the substance is administered through the oralcavity 302, its progression through the remaining cavities of interestis facilitated by nasal exhalation. More specifically, when the userexhales through the nose, a flow of air departing from the lungs 314pushes the administered substance through the laryngeal cavity 304,pharyngeal cavity 306, and nasal cavities 308 to complete the depositionof particles therein. Yet in other embodiments, the user inhales to fillup the lungs 314 and subsequently operates a mechanical device topressure the substance into a flow directed toward the back of the oralcavity 302. Since the lungs are filled up, the flow cannot progresstowards the lungs 314. Similarly, since the flow is directed towards theback of the oral cavity 302, no substantial volume of the flow canregress back towards the mouth. As a result, the flow is directedtowards the laryngeal cavity 304, pharyngeal cavity 306, and nasalcavities 308 to complete the deposition of particles therein.

In some embodiments, the dose is administered by oral inhalation, whichis to be arrested before admission of any substantial quantity of thesubstance into the trachea, lower airways and lungs 314. During thefollowing nasal exhalation, a flow of air departing from the lungs 314pushes the inhaled substance through the laryngeal cavity 304,pharyngeal cavity 306, and nasal cavities 308 to complete the depositionof particles therein. Yet in other embodiments, the dose is administeredby operating a mechanical means that pressures the substance into a flowdirected towards the back of the oral cavity 302. As mentionedpreviously, prior to operating the mechanical means, the user fills upthe lungs 314, thereby preventing admission of the flow therein.

In some embodiments, the substance is sprayed into an antistatic chamberin fluid communication with a mouthpiece. While in the antistaticchamber, the particles of the substance are maintained in suspensionuntil they are drawn from the chamber and into the mouthpiece beforeentering the oral cavity 302. The particles can be drawn by oralinhalation from the mouthpiece or by operation of a mechanical meansthat pressures the particles out of the chamber and into the mouthpiece.In other embodiments, the substance is released in powder form, and theparticles of the substance are maintained in suspension until they aredrawn into the mouthpiece before entering the oral cavity 302. Theparticles can be drawn by oral inhalation from the mouthpiece or byoperation of a mechanical means that pressures the particles out intothe mouthpiece.

The operation of the mechanical means can consist in collapsing achamber, which reduces its capacity, thereby pressuring its content intoa flow directed towards the mouthpiece. For exemplary purposes, thechamber can be a bellows collapsible under two opposite forces exertedby the user thereon. Alternatively, the mechanical means can consist ina plunger moveably mounted within a chamber, wherein the user can movethe plunger against the chamber's content to produce a flow directedtowards a mouthpiece.

In embodiments where the dose is administered by oral inhalation, theuser is to inhale a volume greater than a first threshold, whichprovides for the deposition of particles in the upper respiratory tract,namely the oral cavity 302, the laryngeal cavity 304, the pharyngealcavity 306, and the nasal cavities 308, yet smaller than a secondthreshold to minimize deposition into the trachea, lower airways andlungs 314.

In some embodiments, the oral inhalation is to be arrested by the userin a timely manner, which is challenging as the lapse of time betweenreaching the first and second thresholds is short. The user is likely tomistime arrestment, stopping short of the first threshold for fear ofinhaling into the trachea, lower airways and lungs 314, or staying thecourse after the second threshold has been reached, for fear of inhalingan insufficient dose. For this reason, in some embodiments, the rate atwhich the aerosolized substance is inhaled is restricted so as to extendthe lapse of time between reaching the first and second thresholds andenable the user to arrest inhalation in a timely manner. For instance,in embodiments where the substance is inhaled from a chamber through amouthpiece, the outlet through which the chamber communicates with themouthpiece can be sized so as to sufficiently reduce the flow rate.Alternatively, a sensor mounted in the mouthpiece or chamber can measurethe volume moved from the chamber and into the mouthpiece, and emit asignal indicating to the user that oral inhalation is to be arrested.

In yet another embodiment, the chamber is a bag that gradually collapsesas its content is orally inhaled, the bag being configured to reach arecognizable state of collapse when oral inhalation is to be arrested.

In other embodiments, the inhalation is to be arrested automatically,without any intervention on the part of the user. For instance, inembodiments where the substance is orally inhaled from a chamber througha mouthpiece, a sensor mounted in the mouthpiece or chamber can measurethe volume moved from the chamber and into the mouthpiece, and emit asignal once the volume reaches the first threshold. A shutter mountedwithin the chamber or the mouthpiece interrupts the flow in response tothe signal, thereby ensuring arrestment of inhalation and minimizing theamount of substance that reaches the trachea, lower airways and lungs314.

The first and second thresholds may vary according to the user profile.For instance, if the condition to be treated is severe, a greater dosemay be preferred, which translates into a greater first threshold.However, if the user is a child, the respiratory tract is shorter, whichtranslates into a smaller second threshold. In some embodiments, themethod of the present invention comprises the step of adjusting thesensor according to the user's profile so as to ensure that arrestmentis either suggested to the user or automatically performed in a timelymanner. In embodiments where the substance is orally inhaled from thechamber through a mouthpiece, the size of the outlet between the chamberand mouthpiece can be variably restricted using an adjustable valve soas to tailor the rate at which the content is inhaled. For instance, ifthe user is a child with a severe condition, the lapse of time betweenreaching the first and second thresholds may be shorter than for otherusers, and therefore, the valve can be adjusted to further restrict thesize of the outlet.

The method of the present invention can be used for the treatment of amedical condition of the upper respiratory tract by providing for thedelivery of a therapeutically effective dose of a medicament in the oralcavity 302, the laryngeal cavity 304, the pharyngeal cavity 306, and thenasal cavities 308. For instance, it can be used for the treatment ofallergic and non-allergic rhinitis, rhinosinusitis, and upper airwaycough syndrome by providing for the delivery of a therapeuticallyeffective dose of an aerosolized corticosteroid. In some embodiments,the therapeutically effective dose of an aerosolized corticosteroid forthe treatment of allergic and non-allergic rhinitis, rhinosinusitis, andupper airway cough syndrome is from 25 to 1000 micrograms.Alternatively, the method of the present invention can be used for thetreatment of a non-medical condition of the upper respiratory tract byproviding for the delivery of an effective dose of a substance in theoral cavity 302, the laryngeal cavity 304, the pharyngeal cavity 306,and the nasal cavities 308. Alternatively, the method of the presentinvention can be used for the treatment of a medical condition byproviding for the expedited delivery of a therapeutically effective doseof a medicament into the bloodstream through the lining of the oralcavity 302, the laryngeal cavity 304, the pharyngeal cavity 306, and thenasal cavities 308, and this, even if the condition to be treated failsto affect the upper respiratory tract. For instance, the method can beused to expeditiously deliver a therapeutically effective dose ofsumatriptan into the bloodstream for the treatment of migraines.

The Applicant has performed two rounds of testing on a patient sufferingfrom post-nasal drip and upper laryngeal syndrome with an interval oftwo weeks between the rounds, each round consisting in administering atherapeutically effective dose of ciclesonide using the method of thepresent invention. Immediately prior to each one of the rounds, thepatient reported experiencing symptoms typical of upper airway coughsyndrome, yet following each one of the rounds, the patient reported asignificant alleviation of the symptoms. In some embodiments, thetherapeutically effective dose of ciclesonide for the treatment of upperairway cough syndrome is from 25 to 800 micrograms. Use of ciclesonidefor the treatment of upper airway cough syndrome provides the advantageof avoiding fungal infections typically associated with administrationof corticosteroid in the posterior nasal region, pharynx and the larynx.

In conducting the rounds of testing, the Applicant used the embodimentof the oral delivery device of the present invention shown in FIG. 3.The oral delivery device had an effective volume of 375 milliliters. Itshould be noted that in some embodiments, the effective volume isgreater or smaller than 375 milliliters. In operation, the patientreleased two sprays of aerosolized ciclesonide into the oral deliverydevice, each one of the sprays containing 200 micrograms of ciclesonide,and performed four to six oral inhalations, each one of the inhalationsbeing followed by a nasal exhalation into the ambient atmosphere. Eachone of the inhalations drew ambient air into the oral delivery device tosweep in an additional amount of aerosolized ciclesonide. On average,the patient admitted 16 milliliters of aerosolized ciclesonide into theoral cavity 302, the pharyngeal cavity 306, the laryngeal cavity 304,the tracheal cavity 310, and the nasal cavities 312. Each one of theinhalations generated a peak negative pressure ranging from minus 34 tominus 65 cm H₂O, for an average of minus 50.5 cm H₂O. While the patientexhaled, the soft palate of the roof of the mouth closed against thetongue, which prevented oral exhalation. The subsequent mouth negativepressure drew ambient air to replenish the oral delivery device for thesubsequent inhalation. The combination of one inhalation and oneexhalation was performed at a frequency of approximately 24 times perminute. The series of four to six inhalations and exhalations wasperformed once in the morning and once in the evening for two weeks.After each series of inhalations and exhalations, the subject rinsed themouth with water to minimize ciclesonide in the oral cavity.

In some embodiments of the method of the present invention, the deliveryof the dose is distributed over several iterations of the previouslydisclosed step of orally administering the substance, each iterationproviding for the delivery of a sub-dose, the sub-dose having beenestablished as a function of the dose to be delivered and the number ofiterations.

In some embodiments, the method of the present invention comprises thestep of adjusting the number of iterations according to the user'sprofile. For instance, if the user is a child with a severe condition,the lapse of time between reaching the first and second thresholds maybe shorter than for other users. Distribution over several iterations isparticularly useful in such cases. When orally administering a sub-doserather than a dose, the first threshold is reached in a shorter amountof time, thereby extending the lapse of time between reaching the firstand second thresholds.

While the method of the present invention has been described asinvolving minimizing inhalation into the trachea, lower airways andlungs 314, it can alternatively involve minimizing of inhalation intoother regions within the respiratory tract, such as the trachea 310 andthe primary bronchi 312. Yet in other embodiments, the method caninvolve inhalation into the trachea 310, but minimizing the amount intothe trachea 310, primary bronchi 312 and the lungs 314. Arrestment ofthe flow, whether performed by the user or by a mechanism such as ashutter operated by a sensor would be adjusted accordingly.

The method of the present invention can be performed using a variety ofdevices. It is an object of the present invention to provide an oraldelivery device for effective deposition of particles in the oral,laryngeal, pharyngeal, and nasal cavities while minimizing depositioninto the trachea, lower airways and the lungs.

Referring now to FIG. 2, there is shown a first embodiment of an oraldelivery device 100 having a mouthpiece 102 and a delivery regulator inthe form of a flow restrictor. The flow restrictor has a molded plasticchamber 104, which is hermetically sealed, cylindrical, and of suitablesize, weight, and shape to be held in a human hand. The chamber 104 hascylindrical sidewalls 106, a transverse top wall 108, and a transversebottom wall 110, all of which are preferably made of antistatic materialor coated with antistatic material to limit, if not prevent,accumulation of particles thereon. It is important to note that in someembodiments, the cylindrical sidewalls 106, transverse top wall 108, andtransverse bottom wall 110, are neither made of nor coated withantistatic material.

Integral with the top wall 108 is a smaller cylindrical wall 112extending away from the chamber 104 to define an aperture in which acartridge 114 of pressurized substance 116 is received. The cartridge114 has a nozzle 118 extending towards the top wall 108 and into asubstance inlet 120, which takes the form of a spout extending from thetop wall 108 and into the chamber 104, thereby establishing a fluid,one-way communication between the chamber 104 and the cartridge 114. Thesubstance inlet 120 holds a diffuser 122 therein, which is porous andcan be made from rigid material such as plastic, or flexible materialsuch as rubber. Upon depression of the cartridge 114 towards the topwall 108, a measured dose of substance 116 is dispensed in aerosolizedform within the chamber 104 through the substance inlet 120. Due to thepossible antistatic nature of the sidewalls 106, the top wall 108, andthe bottom wall 110, more of the dispensed particles of the substance116 will remain in suspension within the chamber 104 until inhalationfrom the mouthpiece 102.

The bottom wall 110 defines an air inlet 124 that establishes a fluidone-way communication between the ambient atmosphere and the chamber104. The air inlet 124 admits air from the ambient atmosphere and intothe chamber 104, but limits the release of the content 126 of thechamber 104 into the ambient atmosphere.

Integral with the sidewalls 106 and extending away from the chamber 104is a cylindrical wall 128 defining a mouthpiece 102. The mouthpiece 102is of suitable size and shape to be received within the mouth of theuser. The sidewalls 106 also define an outlet 130 establishing a fluid,one-way communication between the chamber 104 and the mouthpiece 102.When the user places the mouthpiece 102 in the mouth and inhales, theair inlet 124 admits ambient air into the chamber 104 to produce a flow,and the outlet 130 admits the produced flow from the chamber 104,through the mouthpiece 102, and into the respiratory tract.

The user is to inhale a volume greater than a first threshold, whichprovides for the deposition of particles in the upper respiratory tract,yet smaller than a second threshold to minimize deposition into thetrachea, lower airways and lungs. The oral inhalation is to be arrestedby the user in a timely manner, which is challenging as the lapse oftime between reaching the first and second thresholds is short. The useris likely to mistime arrestment, stopping short of the first thresholdfor fear of inhaling into the lungs, or staying the course after thesecond threshold has been reached, for fear of inhaling an insufficientdose. For this reason, the air inlet 124 and the outlet 130 are sized torestrict the rate at which the aerosolized substance is inhaled isrestricted so as to extend the lapse of time between reaching the firstand second thresholds and enable the user to arrest inhalation in atimely manner.

In operation, the user places the mouthpiece 102 in the mouth anddepresses the cartridge 114 towards the top wall 108, in response towhich a measured dose of the substance 116 is dispensed therefrom. Thediffuser 122 aerosolizes the dispensed substance 116 before it entersthe chamber 104 through the substance inlet 120. Particles of thesubstance 116 remain suspended in the chamber 104 until the user inhalesfrom the mouthpiece 102, whereupon air is drawn from the ambientatmosphere and into the chamber 104 through the air inlet 124 to mixwith the particles of the substance 116. The mixture flows from thechamber 104 and into the mouthpiece 102 through the outlet 130 beforeentering the oral and laryngeal cavities. The air inlet 124 and theoutlet 130 are sized to restrict the rate at which the mixture flows soas to enable the user to arrest inhalation in a timely manner, beforethe flow is admitted into the trachea, lower airways and lungs. Morespecifically, as the user inhales, the rate at which the content 126evacuates the chamber 104 is greater than the rate at which it isreplenished. As the chamber 104 is depleted of the content 126,resistance to inhalation increases, leading to a growing discomfort onthe part of the user. Upon feeling substantial discomfort, the userarrests inhalation and exhales the flow through the pharynx and out fromthe nose. As the flow travels through the upper respiratory tract,particles of the substance 116 are deposited in the oral, laryngeal,pharyngeal, and nasal cavities, and this, with minimal deposition withinthe trachea, lower airways and lungs. While the user exhales, thechamber 104 is replenished with air through the air inlet 124. It isimportant to note that the oral delivery device 100 enables the user totarget areas of the upper respiratory tract that would otherwise bedifficult to reach through nasal inhalation due to the anatomicallandscape of the nasal cavities. This is achieved while minimizinginhalation of the substance 116 into the trachea, lower airways andlungs, which would result in a waste of the substance 116, if not indamage to the trachea, lower airways and lungs.

The Applicant has found that in an oral delivery device having amouthpiece adapted to be received in the mouth for oral inhalation of asubstance in aerosol or powder form into the upper respiratory tract, aflow restrictor in the form of a chamber in fluid communication with theambient atmosphere and the mouthpiece through an air inlet and anoutlet, at least one of which is sized to restrict the inhalation rates,enables the user to arrest inhalation in a timely manner, therebyproviding the advantage of an efficient delivery of particles of theaerosolized substance to the upper respiratory tract, namely the oral,laryngeal, pharyngeal, and nasal cavities with limited deposition in thetrachea, lower airways and lungs.

While the air inlet 124 and the outlet 130 have been described as sizedto restrict the inhalation rate so as to enable the user to arrestinhalation in a timely manner, in an alternative embodiment, only one ofthe air inlet 124 and the outlet 130 is sized to achieve suchrestriction. Also, while the air inlet 124 and outlet 130 have beendescribed as sized to achieve such restriction, they can alternativelybenefit from a valve mounted therein to adjust their size asappropriate. According to yet another embodiment, at least one of theair inlet 124 and outlet 130 benefits from a valve that can be adjustedto tailor the restriction of the inhalation rates according to theuser's profile. For instance, since the respiratory tract of a child isnot as lengthy as that of an adult, the valve can be adjusted forgreater restriction. Also, while the substance inlet 120, the air inlet124, and the outlet 130 have been described as establishing one-waycommunications, at least one of them may alternatively establish atwo-way communication that does not compromise the effectiveness of theoral delivery device 100.

While the mouthpiece 102 has been described as tubular, it canalternatively take other forms. For instance, the mouthpiece 102 cantake the form of a facemask that enables inhalation of the content 126through the oral airway, but not through the nasal airways. Also, whilethe oral delivery device 100 has been described as presenting themouthpiece 102 and the chamber 104 along perpendicular axes, it canalternatively present the mouthpiece 102 and the chamber 104 along asame axis, as shown in FIG. 3.

While the chamber 104 has been described as having the air inlet 124, itcan alternatively be devoid of any inlets other than the substance inlet120. As the user inhales from the mouthpiece 102, the content 126 of thechamber 104 is gradually depleted until a vacuum state is reached, atwhich point inhalation is arrested. The capacity of the chamber 104 issufficiently small so that a vacuum state is reached, thereby arrestinginhalation before substantial flow reaches the lungs. The capacity isalso sufficiently large for the flow to travel through the mouth andlarynx during oral inhalation and through the pharynx and nose duringnasal exhalation, whereby particles of the aerosolized substance aredeposited in the oral, laryngeal, pharyngeal, and nasal cavities as theflow travels through the upper respiratory tract.

While the capacity of the chamber 104 has been described as fixed, itcan alternatively be adjustable according to the user's profile prior touse. For instance, since the respiratory tract of children is not aslengthy as that of adults, the capacity of the chamber can be reduced toaccommodate children, or conversely expanded to accommodate adults. Inone embodiment, and as shown in FIG. 7, the chamber 104 can be a bellowscollapsible and expandable to adjust its capacity. Alternatively, in anembodiment shown in FIG. 6, the flow restrictor can have a plunger 136moveably mounted within the chamber 104 to adjust its capacity.

In some embodiments, the oral delivery device 100 presents a flowrestrictor having a chamber 104 in the form of a bag collapsible overthe course of inhalation. The bag is made from flexible material such asplastic that shrivels as the flow travels into the mouthpiece 102. Inoperation, the user places the mouthpiece 102 in the mouth and depressesthe cartridge 114, in response to which a measured dose of the substance116 is dispensed therefrom and processed into an aerosolized form priorto admission into the chamber 104. Particles of the substance 116dispensed remain suspended in the chamber 104 until the user inhalesfrom the mouthpiece 102, whereupon the content 126 of the chamber 104flows into the mouthpiece 102 through the outlet 130, before enteringthe oral and laryngeal cavities. Over the course of inhalation, thechamber 104 collapses towards the mouthpiece 102 until it reaches astate of collapse indicating that the inhalation is to be arrested. Asubsequent nasal exhalation completes the deposition of particles of thesubstance 116 within the oral, laryngeal, pharyngeal, and nasal cavitieswith limited deposition in the trachea, lower airways and lungs.

Referring now to FIG. 4, there is shown a third embodiment of the oraldelivery device 100 presenting the mouthpiece 102 and a flow restrictorhaving the chamber 104, a sensor 146, and a shutter 148. The chamber 104is in fluid communication with the ambient atmosphere through the airinlet 124 and in fluid communication with the mouthpiece 102 through theoutlet 130. When the user inhales from the mouthpiece 102, air is drawnfrom the ambient atmosphere and into the chamber 104 through the airinlet 124. The sensor 146, mounted within the air inlet 124, measuresthe volume of air drawn into the chamber 104, which corresponds to thevolume of flow drawn from the chamber 104 and into the mouthpiece 102for oral inhalation. Once the measured volume is sufficiently large forthe deposition of particles of the substance 116 in the oral, laryngeal,pharyngeal, and nasal cavities, yet sufficiently small to limitdeposition in the trachea, lower airways and lungs, the sensor 146 emitsa signal in response to which the shutter 148, mounted in the outlet130, closes the outlet 130 to arrest inhalation and minimize the flowfrom reaching the trachea, lower airways and lungs.

In operation, the user places the mouthpiece 102 in the mouth anddepresses the cartridge 114 towards the top wall 108, in response towhich a measured dose of the substance 116 is dispensed therefrom andaerosolized by the diffuser 122 before being admitted into the chamber104 through the substance inlet 120. Particles of the substance 116remain suspended in the chamber 104 until the user inhales from themouthpiece 102, whereupon air is drawn from the ambient atmosphere andinto the chamber 104 through the air inlet 124 to mix with the particlesof the substance 116. The mixture flows from the chamber 104 and intothe mouthpiece 102 through the outlet 130, before entering the oral andlaryngeal cavities. The sensor 146, mounted within the air inlet 124,measures the volume of air drawn into the chamber 104, which correspondsto the volume of the flow drawn out from the chamber 104 and into themouthpiece 102 for oral inhalation. Once the measured volume issufficiently large for the deposition of particles of the substance 116in the oral, laryngeal, pharyngeal, and nasal cavities, yet sufficientlysmall to limit deposition in the lungs, the sensor 146 emits a signal inresponse to which the shutter 148, mounted in the outlet 130, closes theoutlet 130 to arrest inhalation and minimize the flow from reaching thetrachea, lower airways and lungs. The user subsequently exhales the flowthrough the pharynx and out from the nose. As the flow travels throughthe upper respiratory tract, particles of the substance 116 aredeposited in the oral, laryngeal, pharyngeal, and nasal cavities, andthis, with minimal deposition within the trachea, lower airways andlungs.

While the sensor 146 has been described as measuring the air drawn intothe chamber 104, it can exclusively conduct such measurements upondepression of the cartridge 114, thereby limiting needless operation ofthe sensor 146 and shutter 148. Also, in some embodiments, the sensormay be controlled to set the threshold volume that triggers the emissionof a signal according to the user's profile. For instance, since therespiratory tract of children is not as lengthy as that of adults, thethreshold volume can be decreased accordingly.

While the embodiment shown in FIG. 4 has been described as having thesensor 146 and the shutter 148, it can alternatively be devoid ofshutters, in which case the sensor 146 emits a signal perceivable by theuser, such as an audio signal, and indicating thereto that the oralinhalation is to be arrested to minimize the flow from reaching thelungs. Also, while the sensor 146 has been described as mounted withinthe air inlet 124, it can alternatively be mounted elsewhere within theoral delivery device 100, such as within the outlet 130, wherein thesensor 146 measures the volume of content admitted from the chamber 104and into the mouthpiece 102. While the shutter 148 has been described asmounted in the outlet 130, it can alternatively be mounted elsewherewithin the delivery device 100, such as within the mouthpiece 102.

In some embodiments, the delivery device 100 of the present inventioncan be retrofitted on an asthma inhaler, and presents a mouthpiece inthe form of an attachment as well as a flow restrictor. The attachmenthas a proximal end from which the user can inhale and a distal end,mountable within the mouthpiece 102 of the asthma inhaler by frictionfit. The flow restrictor consists in an extension at the distal end ofthe attachment, the extension defining an opening establishing a fluidcommunication with the asthma inhaler. The opening is sized to restrictthe inhalation rates so as to enable the user to arrest inhalation in atimely manner, namely after having inhaled a volume sufficiently largefor the deposition of particles in the upper respiratory tract, yetsufficiently small to minimize deposition in the trachea, lower airwaysand lungs.

Referring now to FIG. 5, there is shown a fourth embodiment of the oraldelivery device 100 presenting a mouthpiece 102 and a flow restrictor.The mouthpiece 102 presents a proximal end for inhaling the content ofthe mouthpiece 102, and a distal end defining an air opening 154. Theflow restrictor presents a sensor 146 and a shutter 148. When the userinhales from the mouthpiece 102, air is drawn from the ambientatmosphere and into the chamber 104 through the air opening 154 toproduce a flow. The sensor 146, mounted within the air opening 154,measures the volume of air drawn into the mouthpiece 102, whichcorresponds to the volume of flow drawn from the mouthpiece 102 and intothe upper respiratory tract. Once the measured volume is sufficientlylarge for the deposition of particles of the substance 116 in the oral,laryngeal, pharyngeal, and nasal cavities, yet sufficiently small tolimit deposition in the lungs, the sensor 146, mounted within the airopening 154 emits a signal in response to which the shutter 148, mountedwithin the mouthpiece 102, closes the mouthpiece 102 to arrestinhalation and minimize the flow from reaching the trachea, lowerairways and lungs.

In operation, the user places the mouthpiece 102 in the mouth anddepresses the cartridge 114, in response to which a measured dose of thesubstance 116 is dispensed and aerosolized before it enters themouthpiece 102. As the particles of the substance 116 enter themouthpiece 102, the user inhales, drawing air from the ambientatmosphere through the air opening 154 and into the chamber 104 to mixwith the particles of the substance 116. The resulting mixture flowsinto the oral and laryngeal cavities. The sensor 146, mounted within theair opening 154, measures the volume of air drawn into the mouthpiece102, which corresponds to the volume of mixture inhaled. Once themeasured volume is sufficiently large for the deposition of particles ofthe substance 116 in the oral, laryngeal, pharyngeal, and nasalcavities, yet sufficiently small to limit deposition in the lungs, thesensor 146 emits a signal in response to which the shutter 148, mountedin the mouthpiece 102, closes the mouthpiece 102 to arrest inhalation,thereby preventing any substantial flow from reaching the trachea, lowerairways and lungs. The user subsequently exhales the flow through thepharynx and out from the nose. As the flow travels through the upperrespiratory tract, particles of the substance 116 are deposited in theoral, laryngeal, pharyngeal, and nasal cavities, and this, with limiteddeposition within the trachea, lower airways and lungs.

The Applicant has found that in an oral delivery device having amouthpiece configured to directly receive a substance therein, themouthpiece having an air opening at a distal end, the air opening beingin fluid communication with the ambient atmosphere, the proximal endbeing adapted to be received in the mouth for oral inhalation of thesubstance mixed with air drawn from the ambient atmosphere through theair opening, a flow restrictor having a sensor and a shutter, the sensorfor measuring the volume inhaled through the mouthpiece and emitting asignal once the measured volume is sufficiently large for deposition ofparticles in the upper respiratory tract, yet sufficiently small tolimit inhalation into the trachea, lower airways and lungs, and theshutter configured to close the mouthpiece, thereby arrestinginhalation, in response to the signal emitted by the sensor provides theadvantage of an efficient delivery of particles of the aerosolizedsubstance to the upper respiratory tract with limited deposition in thetrachea, lower airways and lungs.

While the sensor 146 has been described as measuring the air drawn intothe mouthpiece 102, it may exclusively conduct such measurements upondepression of the cartridge 114, thereby limiting needless operation ofthe sensor 146 and shutter 148. Also, in some embodiments, the sensor146 may be controlled to set the threshold volume that triggers theemission of a signal according to the user's profile. For instance,since the upper respiratory tract of a child is not as lengthy as thatof an adult, the threshold volume can be decreased accordingly.

The previously disclosed oral delivery device of the present inventionrequires that the user orally inhales a dose of aerosolized substancefrom a mouthpiece for the dose to be delivered to the upper respiratorytract. Use of such a device can present challenges to users havingunderdeveloped lungs, such as children, or to users experiencingpulmonary problems hindering their ability to either inhale or exertcontrol over their inhalation. For these reasons, it is desirable to beprovided with an alternative device that can be used without performingsubstantial inhalation, if any.

Referring now to FIG. 6, there is shown a fifth embodiment of the oraldelivery device 100 according to the present invention, the oraldelivery device 100 presenting the mouthpiece 102 and a flow generatorhaving the chamber 104 and a plunger 136. The chamber 104 is of capacityto hold a volume which, when administered into the upper respiratorytract, ensures sufficient deposition of particles in the oral,laryngeal, pharyngeal, and nasal cavities. Conversely, the capacity issuch that no additional volume can be held beyond that which isnecessary, thereby minimizing needless and potentially harmfuloverexposure to the administered substance. The chamber 104 is in fluidcommunication with the mouthpiece 102 through an outlet 130 and definesan aperture 156 through which the plunger 136 is moveably mounted. Theplunger 136 can be moved against the content 130 of the chamber 104 topressure the content 126 into a flow travelling through the outlet 130and into the mouthpiece 102 before entering the upper respiratory tract.The plunger 136 can be moved in the opposite direction to draw in airfrom the ambient atmosphere through the mouthpiece 102.

The fifth embodiment presents two distinct modes of operation. Under thefirst mode of operation, the user places the mouthpiece 102 in the mouthand depresses the cartridge 114 towards the top wall 108, in response towhich a measured dose of the substance 116 is dispensed and aerosolizedby the diffuser 122 before it enters the chamber 104 through thesubstance inlet 120. Particles of the substance 116 remain suspended inthe chamber 104 until the user operates a handle 132 to move the plunger136 against the content 126 of the chamber 104, thereby pressuring thecontent 126 into a flow that travels through the outlet 130 and into themouthpiece 102, before entering into the oral cavity. As the plunger 136moves along the chamber 104 to a first position, the user inhalessufficiently to admit the portion of the content 126 pressured into themouthpiece 102, but not enough to admit the remainder of the content126. The process is repeated until the chamber 104 is depleted of thecontent 126, at which point the plunger 136 is pulled back towards thebottom wall 110 to replenish the chamber 104 with air. Under thisparticular mode of operation, the movement of the plunger 136 towardsthe top wall 108 reduces the volume of the chamber 104 by the volume ofthe content 126 pressured into the mouthpiece 102. As a result, theportion of the content 126 held in the chamber 104 is at atmosphericpressure and maintains its concentration of aerosolized substance forgreater consistency from one inhalation to another.

Alternatively, under the second mode of operation, the user inhales tofill up the lungs, places the mouthpiece 102 in the mouth and depressesthe cartridge 114 towards the top wall 108, in response to which ameasured dose of the substance 116 is dispensed and aerosolized by thediffuser 122 before it enters the chamber 104 through the substanceinlet 120. Particles of the substance 116 remain suspended in thechamber 104 until the user operates a handle 132 to move the plunger 136against the content 126 of the chamber 104, thereby pressuring thecontent 126 into a flow that travels through the outlet 130 and into themouthpiece 102, before entering into the oral cavity. Since the lungsare filled up, the flow would have limited progression towards thetrachea, lower airways and lungs. Similarly, since the flow is directedtowards the back of the oral cavity, no substantial volume of the flowcan regress back towards the mouth. As a result, the flow is directedtowards the larynx, the pharynx, and the nose to complete the depositionof particles therein. Once the plunger 136 reaches the upper wall 108,the flow is arrested as the volume administered provides for sufficientdeposition of particles in the upper respiratory tract. The user canthen return to normal breathing.

The Applicant has found that in an oral delivery device for delivering adose of a substance in the respiratory tract, the oral delivery devicehaving a mouthpiece adapted to be received in the mouth for oraladmission of a flow of the substance into the respiratory tract, a flowgenerator for pressuring the substance into the flow travelling throughthe mouthpiece, into the mouth, and out from the nose while inhalationis avoided, and for enabling arrestment of the flow once the flowreaches a volume sufficient for a deposition of particles of theaerosolized substance in the oral, laryngeal, pharyngeal, and nasalcavities provides the advantage of effective deposition of particles inthe oral, laryngeal, pharyngeal, and nasal cavities following nasalexhalation, and this, with limited deposition in the trachea, lowerairways and lungs.

While it was mentioned that prior to operating the oral delivery device100, the user inhales to fill up the lungs, thereby preventing the flowfrom progressing towards the trachea, lower airways and lungs as thesubstance 116 is administered, the user is not required to hold breathuntil arrestment of the flow. Alternatively, the user can nasally exhaleduring administration of the substance, thereby encouraging the flow toprogress towards the pharynx and the nose after it reaches the larynx.

While the flow generator has been described as comprising the chamber104 and the plunger 136, it can alternatively comprise the chamber 104in the form of a bellows, as shown in FIG. 7, wherein the chamber 104can be contracted to pressure the content 130 into a flow directedtowards the mouthpiece 102, and expanded to draw air from the ambientatmosphere through the mouthpiece 102 and into the chamber 104.

Yet in another embodiment, and referring to FIG. 8, the flow generatorcomprises a ventilation element or fan 156 (for example using batterypower) mounted in the air inlet 124 for drawing air from the ambientatmosphere and into the chamber 104 to generate a flow directed towardsthe mouthpiece 102. The ventilation element 156 can be configured fordirect activation by the user, whereby after the aerosolized substanceis dispensed within the chamber 104, the user can chose the time atwhich the administration of the substance is to be initiated.Alternatively, the ventilation element 156 can be configured foractivation upon depression of the cartridge 114, whereby fewer steps arerequired on the part of the user. The ventilation element 156 can beconfigured to automatically turn off after a specific amount of time,which amount of time is such that the volume administered provides forsufficient deposition of particles in the respiratory tract. In yetanother embodiment, a sensor measures the volume drawn into themouthpiece 102 from the chamber 104 and turns off the ventilationelement 156 when the measured volume provides for sufficient depositionof particles in the respiratory tract. In some embodiments, theventilation element 156 is adjustable according to the user's profile.For instance, the amount of time before the ventilation elements 156automatically turns off can be reduced if the user is a child.

While the capacity of the chamber 104 has been described as beinglimited such that no additional volume can be held beyond that which isnecessary, it can alternatively hold a greater volume, yet inform theuser when a sufficient volume has been administered. For instance, inthe embodiment shown in FIG. 6, the sidewalls 106 can bear markedgraduations, each of which corresponds to a desired volume for adistinct user profile. Since the respiratory tract of children is not aslengthy as that of adults, the graduation associated with children canbe closer to the bottom wall 110, whereas the graduation associated withadults can be closer to the top wall 108. In operation, the plunger 136is to be arrested at the marking associated with the user's profile.Similar graduations can be marked on the embodiment shown in FIG. 7,wherein the chamber 104 is to be collapsed until it reaches thegraduation associated with the user's profile. Alternatively, thechamber 104 can be sized such that a recognizable state of collapse isachieved when the administration is to be arrested. For instance, thechamber 104 can be sized such that once it collapses in half, theadministration is to be arrested. In yet another embodiment, a sensormounted in the oral delivery device 100 measures the volume drawn intothe mouthpiece 102 from the chamber 104 and emits a signal perceivableby the user when the measured volume provides for sufficient depositionof particles in the upper respiratory tract, the signal informing theuser that the flow is to be arrested. Alternatively, the emitted signalcan activate a shutter mounted within the oral delivery device 100 toarrest the flow. The shutter can arrest the flow by, for instance,closing the outlet 130.

While the oral delivery device of the present invention has beendescribed as delivering substances in aerosol form, it can alternativelybe used to deliver substances in powder form. The embodiments shown inFIG. 2 to FIG. 8 can be adapted for delivery of powder substance to thatend. Referring now to FIG. 9, there is shown an eighth embodiment of theoral delivery device 100 presenting the mouthpiece 102, a powderinhalation device 164, and a flow restrictor having the chamber 104. Thechamber 104 is in fluid communication with the ambient atmospherethrough the air inlet 124, and with the powder inhalation device 164through the outlet 130. As for the power inhalation device 164, it isalso in fluid communication with the mouthpiece 102 through powderinhalation device outlet 160. The content 126 consists of air.

When the user inhales from the mouthpiece 102, the content 126 flowsfrom the chamber 104 and to the powder inhalation device 164 through theoutlet 130 for mixing with the powder substance to be delivered. Theproduces mixture flows through the powder inhalation device outlet 160and into the mouthpiece 102 for oral inhalation. The air inlet 124 issized to restrict the rate at which the mixture is inhaled so as toextend the lapse of time between reaching the first and secondthresholds and enable the user to arrest inhalation in a timely manner.

In operation, the user places the mouthpiece 102 in the mouth andactuates the powder inhalation device 164, in response to which ameasured dose of the powder substance is released in suspension therein.Particles of the powder substance remain suspended in the powderinhalation device 164 until the user inhales from the mouthpiece 102,whereupon air is drawn from the ambient atmosphere and into the chamber104 through the air inlet 124. The content 126 of the chamber 104, whichconsists of air, flows from the chamber 104 and into the powderinhalation device 164 through the outlet 130 for mixing with the powdersubstance. The air inlet 124 is sized to restrict the rate at which themixture flows so as to enable the user to arrest inhalation in a timelymanner, before any substantial flow is admitted into the lungs. Morespecifically, as the user inhales, the rate at which the content 126evacuates the chamber 104 is greater than the rate at which it isreplenished. As the chamber 104 is depleted of the content 126,resistance to inhalation increases, and this, until the user feels asubstantial discomfort, which signals that inhalation is to be arrested.The user subsequently exhales the flow through the pharynx and out fromthe nose. As the flow travels through the upper respiratory tract,particles of the powder substance are deposited in the oral, laryngeal,pharyngeal, and nasal cavities, and this, with limited, if any,deposition within the trachea, lower airways and lungs. It is importantto note that the oral delivery device 100 enables the user to targetareas of the upper respiratory tract that would otherwise be difficultto reach through nasal inhalation due to the anatomical landscape of thenasal cavities. This is achieved while minimizing inhalation of thepowder substance into the trachea, lower airways and lungs, which wouldresult in a waste of the powder substance at best, if not in damages tothe lungs.

What is claimed is:
 1. An oral delivery device for use by a user fordelivering a dose of a substance in aerosol or powder form to the upperrespiratory tract, said delivery device comprising: a mouthpiece adaptedto be received in the mouth for oral admission of a flow of air into theupper respiratory tract; a substance inlet for admitting said substanceso that said flow of air can carry said substance; and a deliveryregulator comprising a flow restrictor for enabling arrestment of oralinhalation before admission by inhalation into the lungs of saidsubstance, whereby nasal exhalation of said flow following saidarrestment completes a deposition of particles of said substance in theoral, laryngeal, pharyngeal, and nasal cavities with limited depositionof said particles in the trachea, lower airways and lungs, said flowrestrictor comprising a chamber in fluid communication with saidmouthpiece having a volume effective to allow said flow into said mouthand an air inlet for admitting ambient air at a restricted rate uponsaid inhalation from said mouthpiece that causes the user to feeldiscomfort, arrest inhalation effort and to exhale out from the nose. 2.The delivery device of claim 1, wherein said substance is in aerosolform.
 3. The delivery device of claim 1, wherein said air inlet is sizedto restrict the rate of said inhalation so as to enable the person towhom said dose is delivered to arrest said oral inhalation in a timelymanner.
 4. The delivery device of claim 3, wherein said flow restrictorcomprises an adjustable valve mounted within said air inlet to adjust arestriction of the rate of said inhalation according to a profile of theperson to whom said dose is delivered so as to enable said person toarrest said oral inhalation in a timely manner.
 5. The delivery deviceof claim 1, wherein said delivery device is adapted for retrofitting onan aerosol or powder medication delivery device.
 6. In combination, thedelivery device of claim 1 and a corticosteroid, said dose of saidcorticosteroid is a therapeutically effective dose for the treatment ofa medical condition selected from the group consisting of an allergicrhinitis, a non-allergic rhinitis, a rhinosinusitis, and an upper airwaycough syndrome.
 7. The combination of claim 6, wherein said substance isciclesonide.